MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SPONGE,NEURO,0.5"X0.5",XR,STRL,10/PK

Catalog Number	NEUROSPNG05H
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During a spinal procedure, a cottonoid patty detached from its string and migrated into the dural space, tracking upward approximately two spinal levels.This caused an intraoperative delay of 1-2 hours due to a search and retrieval effort.The sponge was located using intraoperative o-arm 3d imaging.The procedure was completed, but required extended anesthesia time, increased surgical site size, and additional radiation exposure, along with an overnight hospital stay instead of same-day discharge.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
During a spinal procedure, a cottonoid patty detached from its string and migrated into the dural space, tracking upward approximately two spinal levels.This caused an intraoperative delay of 1-2 hours due to a search and retrieval effort.The sponge was located using intraoperative o-arm 3d imaging.The procedure was completed, but required extended anesthesia time, increased surgical site size, and additional radiation exposure, along with an overnight hospital stay instead of same-day discharge.
Additional Manufacturer Narrative
Update to h6.After further investigation, it has been determined that the investigation involved testing of the actual/suspected device and trend analysis.The investigation found no device problem and concluded that a cause could not be established.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
Update to h6.After further investigation, it has been determined that the investigation involved testing of the actual/suspected device, trend analysis, and an analysis of production records.The investigation found a mechanical stress problem and the cause was determined to be traced to the user.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: SPONGE,NEURO,0.5"X0.5",XR,STRL,10/PK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 23433246
• Report Number: 1417592-2025-00587
• Device Sequence Number: 4782638
• Product Code: HBA
• UDI-Device Identifier: 20080196286659
• UDI-Public: 20080196286659
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: NEUROSPNG05H
• Device Lot Number: 6052502001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 12/05/2025; 12/16/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 12/12/2025; 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Sex: Female